{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T22:47:12Z","timestamp":1783464432943,"version":"3.55.0"},"reference-count":28,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2021,11,24]],"date-time":"2021-11-24T00:00:00Z","timestamp":1637712000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009857","name":"Regeneron Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009857","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Laryngoscope"],"published-print":{"date-parts":[[2022,2]]},"abstract":"<jats:sec><jats:title>Objectives\/Hypothesis<\/jats:title><jats:p>Dupilumab, a fully human monoclonal antibody that blocks the shared interleukin (IL)\u20104\/IL\u201013 receptor component, significantly improved outcomes for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in the SINUS\u201024 and SINUS\u201052 studies. This post hoc analysis evaluated dupilumab's effect on patient\u2010reported symptoms and objective outcome measures using thresholds of clinically meaningful within\u2010patient change from baseline.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with CRSwNP receiving subcutaneous dupilumab or placebo every 2\u2009weeks in SINUS\u201024\/SINUS\u201052 were analyzed. Patients recorded severity of nasal congestion (NC), loss of smell (LoS), and anterior\/posterior rhinorrhea (each within range 0\u20133) daily. Total Symptom Score (TSS) was calculated as a composite severity score (0\u20139) for these symptoms. Objective measures included University of Pennsylvania Smell Identification Test (UPSIT; 0\u201340), nasal polyps score (NPS; 0\u20138), and Lund\u2013Mackay computed tomography score (LMK\u2010CT; 0\u201324). Thresholds of within\u2010patient change in scores from baseline at weeks 24 and 52 considered clinically meaningful were \u22651.0 (NC, LoS), \u22653.0 (TSS), \u22658.0 (UPSIT), \u22651.0 (NPS), and \u22655.0 (LMK\u2010CT).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 724 and 303 patients were included in the week 24 and 52 analyses, respectively. Responder rates were significantly higher with dupilumab versus placebo at week 24 for NC (64% vs. 24%), LoS (63% vs. 14%), TSS (62% vs. 15%), UPSIT (54% vs. 6%), NPS (63% vs. 14%), and LMK\u2010CT (59% vs. 3%); all <jats:italic>P<\/jats:italic>\u2009&lt;\u2009.0001. Results were consistent at week 52.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Significantly greater proportions of dupilumab\u2010treated patients with CRSwNP compared with placebo demonstrated clinically meaningful improvements in patient\u2010reported sinonasal symptoms and objective outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Level of Evidence<\/jats:title><jats:p>2 <jats:italic>Laryngoscope<\/jats:italic>, 132:259\u2013264, 2022<\/jats:p><\/jats:sec>","DOI":"10.1002\/lary.29911","type":"journal-article","created":{"date-parts":[[2021,11,26]],"date-time":"2021-11-26T07:45:07Z","timestamp":1637912707000},"page":"259-264","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["Dupilumab in <scp>CRSwNP<\/scp>: Responder Analysis Using Clinically Meaningful Efficacy Outcome Thresholds"],"prefix":"10.1002","volume":"132","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0895-4998","authenticated-orcid":false,"given":"Chien\u2010Chia","family":"Chuang","sequence":"first","affiliation":[{"name":"Health Economics and Value Assessment Sanofi  Cambridge Massachusetts U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle","family":"Guillemin","sequence":"additional","affiliation":[{"name":"Patient Reported Outcomes Sanofi  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claus","family":"Bachert","sequence":"additional","affiliation":[{"name":"Upper Airways Research Laboratory and Department of Otorhinolaryngology Ghent University  Ghent Belgium"},{"name":"Division of ENT Diseases, CLINTEC Karolinska Institutet  Stockholm Sweden"},{"name":"First Affiliated Hospital Sun Yat\u2010sen University, First Affiliated Hospital  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stella E.","family":"Lee","sequence":"additional","affiliation":[{"name":"Division of Otolaryngology\u2014Head &amp; Neck Surgery Brigham and Women's Hospital, Harvard Medical School  Boston Massachusetts U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter W.","family":"Hellings","sequence":"additional","affiliation":[{"name":"Upper Airways Research Laboratory and Department of Otorhinolaryngology Ghent University  Ghent Belgium"},{"name":"Department of Otorhinolaryngology \u2013 Head and Neck Surgery University Hospitals Leuven  Leuven Belgium"},{"name":"Department of Otorhinolaryngology Amsterdam University Medical Centres, Location AMC  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wytske J.","family":"Fokkens","sequence":"additional","affiliation":[{"name":"Department of Otorhinolaryngology Amsterdam University Medical Centres, Location AMC  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Duverger","sequence":"additional","affiliation":[{"name":"Division of Immuno\u2010inflammation Sanofi  Chilly\u2010Mazarin France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chunpeng","family":"Fan","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Programming Sanofi  Bridgewater New Jersey U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nadia","family":"Daizadeh","sequence":"additional","affiliation":[{"name":"Biostatistics Sanofi  Cambridge Massachusetts U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikhil","family":"Amin","sequence":"additional","affiliation":[{"name":"Clinical Sciences Global Development Regeneron Pharmaceuticals, Inc.  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Tarrytown New York U.S.A."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,11,24]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaip.2016.04.012"},{"key":"e_1_2_6_3_1","first-page":"343","article-title":"The GALEN rhinosinusitis cohort: chronic rhinosinusitis with nasal polyps affects health\u2010related quality of life","volume":"57","author":"Khan A","year":"2019","journal-title":"Rhinology"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.27852"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.2147\/JAA.S290424"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1749-4486.2012.02527.x"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.3390\/jcm9040925"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.4193\/Rhino16.248"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2018-022644"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2014-006680"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.4193\/Rhin17.255"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/alr.22780"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13601-019-0269-4"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.26391"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/lary.20653"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/alr.22487"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.iac.2018.06.006"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.13685"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cyto.2015.05.008"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1080\/1744666X.2017.1298443"},{"key":"e_1_2_6_21_1","unstructured":"DUPIXENT\u00ae (dupilumab).Prescribing information. 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Accessed March 5 2021."},{"key":"e_1_2_6_27_1","doi-asserted-by":"crossref","unstructured":"HanJ BachertC LeeSE et al.Estimating clinically meaningful change in objective and patient\u2010reported outcomes in inadequately controlled chronic rhinosinusitis with nasal polyps.(Accompanying article);2021.","DOI":"10.1002\/lary.29888"},{"key":"e_1_2_6_28_1","doi-asserted-by":"publisher","DOI":"10.4193\/Rhin20.401"},{"key":"e_1_2_6_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2020.11.013"}],"container-title":["The Laryngoscope"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/lary.29911","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/lary.29911","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/lary.29911","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,21]],"date-time":"2023-08-21T06:43:10Z","timestamp":1692600190000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/lary.29911"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,11,24]]},"references-count":28,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2022,2]]}},"alternative-id":["10.1002\/lary.29911"],"URL":"https:\/\/doi.org\/10.1002\/lary.29911","archive":["Portico"],"relation":{},"ISSN":["0023-852X","1531-4995"],"issn-type":[{"value":"0023-852X","type":"print"},{"value":"1531-4995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,11,24]]},"assertion":[{"value":"2021-06-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-10-12","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-11-24","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}